Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Ortho clinical diagnostics (ortho) has initiated this recall because it was determined that the open pack (in use) storage limits must be reduced from 8 weeks to 4 weeks for vitros immunodiagnostic products total t4 (tt4) reagent packs. this change affects expired current (in date) and future product lots.